Real-world availability of CAR T-cell therapies

Summary

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Blood Podcast Summary: Real-world Availability of CAR T-Cell Therapies

Host: Dr. Laurie Sen (Associate Editor, Blood)
Guest: Dr. Edward Cliff (Peter MacCallum Cancer Centre, Melbourne, Australia)
Date: April 16, 2026
Episode Theme:
A critical discussion of the global landscape of access to commercial CAR T-cell therapies, focusing on findings from the newly published cross-sectional study of Health Technology Assessment (HTA) in G20 countries.

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Main Theme & Purpose

This episode addresses the disparities in approval, funding, and real-world access to CAR T-cell therapies across G20 countries. Dr. Edward Cliff explains the motivations, methodology, and key findings from a comprehensive analysis of how governmental and health systems' decisions shape which patients around the world can benefit from these transformative yet expensive hematological treatments.

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Key Discussion Points and Insights

1. Background & Motivation for the Study

• CAR T-cell therapy is a breakthrough for conditions like acute lymphoblastic leukemia, B-cell lymphomas, and multiple myeloma, but access remains unequal globally due to high costs and logistical hurdles.
• Quote:

  "Most people are well aware that many countries and many patients around the world do not yet have access to CAR T cells... what proportion of patients around the world do have access to CAR T and what are the barriers?"
  (Dr. Edward Cliff, 00:59)

2. Study Methodology & Focus on G20

• The research focused on the G20, covering ~80% of the global population and 85% of global GDP, as a proxy for worldwide trends.
• The study centered on Health Technology Assessment (HTA), the process by which countries evaluate if and when new therapies should receive public funding.
• Explanation of HTA:
  • Most countries have a two-step process—regulatory approval of the product's safety and efficacy, followed by governmental HTA for funding and cost-effectiveness.
  • The U.S. is an exception, often funding immediately post-FDA approval.
• Quote:

  "We’re going to look at this second step in the process, how each country decides, is this a drug or therapy that we want to invest in, that we think is good value for money?"
  (Dr. Edward Cliff, 02:41)

3. Major Findings

• There are 7 FDA-approved commercial CAR T cells, licensed for 18 distinct indications; when considered across the G20, this creates about 250 unique 'therapy-country' scenarios.
• About half of these indications are publicly funded within G20 countries; half are not.
  • The US covers all 18 indications.
  • France & Germany each fund 14.
  • Canada funds 12.
  • Australia lags with just 7.
• Approval Delays:
  • France is roughly 1 year behind the US for new approvals.
  • Singapore and Switzerland exhibit lags of up to 5–6 years.
• Access is not automatic:
  • Government funding ≠ universal patient access, especially considering rurality, logistical hurdles, and care requirements.
• Quote:

  "Some countries, the US has all 18 indications. France and Germany each have 14 of those indications funded... But there's quite a spread... in access."
  (Dr. Edward Cliff, 03:43) "Just because a government funds a therapy doesn't mean that every patient has access... we don't for a second de-emphasise the importance of those other factors in access."
  (Dr. Edward Cliff, 04:32)

4. Factors Driving Variation in Global Access

• The pace and willingness of government bodies vary; however, very few therapies are outright rejected (only 6/250 scenarios); most delays arise from companies' strategic submission timing.
• Strategic non-submission: Manufacturers often delay or defer submitting approval requests to certain countries to avoid rejection and optimize market conditions.
• Regulatory harmonization: Lack of synchronized processes increases duplication and slows approval—some progress with Europe's new joint HTA process.
• Quote:

  "Out of those 250 indications, only about 6 were actually rejected... many companies are looking before they even submit their approvals... there's a kind of actual strategic non-submission going on."
  (Dr. Edward Cliff, 05:10)

5. The Economic Context & Global Disparities

• The distribution of CAR T-cell access is a microcosm of broader inequities in the global oncology market, shaped by economics, regulation, and system capacities.
• Expensive and complex therapies like CAR T tend to amplify these disparities.
• Multi-pronged solutions are needed: scientific innovation (e.g., homegrown CAR T), pricing strategies, regulatory reforms, and global cooperation.
• Quote:

  "CAR T... amplifies exactly what Dr. Janai was explaining, which is that because it’s so expensive and logistically more difficult... it sort of amplifies that disparity. And I think that this is kind of an urgent problem."
  (Dr. Edward Cliff, 06:48)

6. Implications & Hopes for Policy

• The study serves as a call to action for:
  • Companies to seek approval globally and rapidly.
  • Regulators to harmonize processes.
  • Clinicians to advocate for expanded access.
  • Policymakers to consider new therapies (like bispecific antibodies) that might be more accessible in under-resourced settings.
• Quote:

  "I hope that companies will submit their products as quickly as possible around the world to... get these impactful therapies to patients as quickly as possible. I hope that it serves as really an urgent call..."
  (Dr. Edward Cliff, 08:00)

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Notable Quotes & Memorable Moments

• "CAR T has been pretty miraculous, really, for us hematologists and our patients."
  (Dr. Edward Cliff, 00:59)
• "There's another layer... many companies are... thinking about strategically, well, where and when should we actually submit our application for funding?"
  (Dr. Edward Cliff, 05:20)
• "CAR T... offers an interesting perspective on that kind of global challenge and global disparity in access."
  (Dr. Edward Cliff, 07:39)
• "Not everyone in the world, in fact a large majority of the world, doesn't have access to CAR T cells readily, but maybe they will be able to have access to bispecific antibodies if we can get the cost of those down enough."
  (Dr. Edward Cliff, 08:27)

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Key Timestamps

• 00:59 – Background: Barriers to global CAR T access and study motivation
• 01:53 – Rationale for focusing on the G20 and Health Technology Assessment
• 03:35 – Major findings: country variations, funding, and delays
• 05:03 – Insights into why delays and gaps persist
• 06:48 – Commentary on economic and geographic factors in CAR T access
• 08:00 – Aspirations for policy change and practical impact

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Conclusion

This episode underscores the complexities and persistent inequities surrounding global access to CAR T-cell therapies. Dr. Cliff's study not only highlights where and why gaps exist across the G20 but also frames the urgent need for policy innovation, commercial responsiveness, and continued clinical advocacy to ensure more patient lives can benefit from these cutting-edge hematological treatments.

For more details, read the full article at bloodjournal.org.

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Transcript

[A]

Welcome to the American Society of Hematology Conversations with Blood Authors Podcast. This episode is hosted by Associate Editor Dr. Laurie Sen. She discusses Global Access to Commercial CAR T cells, a Cross Sectional Study of Health Technology Assessment of CAR t in the G20 with Dr. Edward Cliff.

[B]

Hi, I'm Laurie Sen, podcast editor at Blood, and I'm joined today by Dr. Edward Cliff from the Peter MacCallum Cancer center in Melbourne, Australia. He's the senior author of a new blood journal article entitled Global Access to Commercial CAR T Cells, A Cross Sectional Study of Health Technology Assessment of CAR t in the G20. Thanks for joining us today.

[C]

Thanks for having me.

[B]

Perhaps you can start by providing some background on the challenges of CAR T cell therapy access and what really motivated you to undertake.

[C]

As you know. Well, Dr. Sen, car T has been pretty miraculous, really, for us hematologists and our patients, both in acute lymphoblastic leukemia, in B cell lymphomas, and in multiple myeloma. But it's a very expensive and logistically challenging therapy. And so most people are well aware that many countries and many patients around the world do not yet have access to CAR T cells. And so really, the motivation for this study was to try and quantify, to try and look at what, well, what proportion of patients around the world do have access to CAR T and what are the barriers? At least it's some of the barriers, because there are many barriers, as I'm sure we'll talk about. But what are the barriers at a health system level, at a government and a public funding level, in different countries around the world, to getting access for more patients to what is a very impactful therapy?

[B]

Can you walk us through your study methodology and the rationale for looking at G20 countries, primarily?

[C]

Ideally, we would have been able to fly to every country in the world and talk to local haematologists and oncologists and hear firsthand what the challenges are in every country around the world. And so really, what we tried to do was design a methodology that would best approximate that as it is, as best as we could. And so the G20 represents about 85% of global GDP and about 80% of the world's population. And so we thought that that was, I guess, a surrogate for as much of the world as we could reasonably take on. And then the next step that I guess many haematologists may or may not know is this sort of funny term, health technology assessment. So in pretty much every country except the United States, the regulatory process is a kind of two Step process. You have a regulatory body, as I'm sure you know, in Canada, in Australia, in much of Europe, much of the world, a regulatory body that looks at is the product well manufactured, is it safe? And then you have a second step where a government body decides, should the government invest in this drug or this therapeutic, is it cost effective, is it effective? And that second step is called hta, or Health Technology Assessment. Funny term, but that's what it's called. And so we said, okay, we're going to take the G20, which represents about 80% of the world and about 85% of the world's GDP. We're going to look at this second step in the process, how each country decides, is this a drug or a therapy that we want to invest in that we think is good value for money? I'm going to use that to try and best approximate what proportion of the world has access to different CAR T cell products and different indications for those CAR T cell products. You know, leukemia, lymphoma, myeloma.

[B]

What were your major findings?

[C]

There are seven FDA approved commercial car T cells across 18 indication, which makes about 250 different indications across the countries that we looked at. And about half of those indications are publicly funded around the world and about half are not. Now, it's quite skewed. Some countries, the US has all 18 indications. France and Germany each have 14 of those indications funded. Canada has 12, unfortunately, a bit further behind in Australia with only seven. But there's quite a spread of different countries having access to different numbers of indications. And then we went on to look at, well, how long does each country take? For example, in France, they're only a bit over a year behind the US on average, across all of the countries. We looked at about a year and a half behind the fda. But then some countries like Singapore and Switzerland, pushing up to five or six years delay between when the FDA and when the local HTA body recommends funding. Now, of course, just because a government funds a therapy doesn't mean that every patient has access. And we very much acknowledge that, although that wasn't a focus of our study. So things like people who live rurally, people who might not be able to afford accommodation, all those logistical steps, people who can't have their cells collected, people who don't have a care to look after them, we don't for a second de emphasise the importance of those other factors in access. It just wasn't a focus of this particular study.

[B]

What are some of the main factors that you think influence that variation in approval between the countries.

[C]

I think at one level the kind of simple answer is that different government bureaucracies take different amounts of time. But I think one of the novel and maybe UNEXP findings was that I think people might have thought that one of the big reasons for that delay was that some HTA bodies were rejecting a lot of therapies. But actually what we found was that out of those 250 indications, only about 6 were actually rejected by the local HCA authorities. Again, there's another layer to it which is that I think what's happening is that many companies are looking before they even submit their approvals to different countries, are thinking about strategically, well, where and when should we actually submit our application for funding? And so I think that there's a kind of actual strategic non submission going on where some manufacturers are choosing when and where they actually submit because they're trying to avoid getting and quite successfully avoid getting negative recommendations. That's a big part of the picture, is how do we encourage more companies to submit their products more widely as quickly as possible. Another part I suppose is I guess, what we call regulatory harmonisation. So trying to get more of the different HTA bodies and regulators around the world to collaborate to try and reduce duplication of that process, which at the moment happens kind of independently in a lot of places. And there's been some movement on that in Europe with a joint HTA process which is just getting up and running in Europe.

[B]

There was an interesting commentary that accompanied your article and Christina Janai from the London School of Economics really stressed the point that the geography of CAR T access reflects the economic architecture of the global oncology market. Can you comment on this?

[C]

I completely agree. I thought it was a very thoughtful commentary and I think that CAR T we looked at as a window that almost kind of amplifies exactly what Dr. Janai was explaining, which is that because it's so expensive and logistically more difficult than your average drug, I think that it sort of amplifies that disparity. And I think that this is kind of an urgent problem and that it needs a lot of different approaches, everything from scientific innovation. You know, one of the things that we only looked a little bit, there's some stuff in the supplementary on academic or homegrown CAR T cells. We hope to do some more research on that in future. But that's one avenue of kind of scientific innovation to try and solve this challenge. We need innovation in terms of pricing, in terms of regulation, in terms of global cooperation. There's kind of a multi pronged approach we need. But I think CAR T we think is interesting as haematologists who prescribe it and give it to patients, but I think it also offers an interesting perspective on that kind of global challenge and global disparity in access.

[B]

What impact do you hope your study might have on informing reimbursement strategies or policy decision processes moving forward?

[C]

I hope that companies will submit their products as quickly as possible around the world to kind of give regulators and HTA bodies around the world the best head start at getting these impactful therapies to patients as quickly as possible. I hope that it serves as really an urgent call to clinicians and to investigators around the world to try and urgently do everything they can in their jurisdictions to increase access to life saving therapies. I think it means that we need to think about therapies through this lens. You know, in lymphoma, for example, we have the rise of bispecific antibodies and I think that that is an element that has to play into this discussion that not everyone in the world, in fact a large majority of the world doesn't have access to CAR T cells readily, but maybe they will be able to have access to bispecific antibodies if we can get the cost of those down enough. So I think it's sort of on one hand a kind of regulatory and a policy and an HTA paper, but I think it also intersects back and forth with a clinical world that we live in as well.

[B]

I think you shed an important spotlight on this really key issue that we're facing right now in immunologic malignancy care, and certainly it's been very insightful. Ultimately. I hope you've enjoyed the conversation today with Eddie Cliff who has discussed the newly published article Global Access to Commercial CAR T Cells, A Cross Sectional Study of Health Technology Assessment of CAR T and the G20. This study explores the factors that can influence global access to CAR T cell therapy and provides insight into the existing inequalities. This article is now available on bloodjournal.org

[A]

thank you for listening to this episode of Conversations with Blood Authors. To read the articles, visit bloodjournal.org this episode is copyrighted by the American Society of Hematology.